Table 2.
Screening | Induction TPE | Maintenance TPE | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Day/month | 0 | 1D | 2D | 3D | 4D | 5D | 1M | 2M | 3M | 4M |
Informed consent | x | |||||||||
In/Exclusion criteria | x | |||||||||
Physical examination* | x | x | x | x | x | x | x | x | x | x |
Neurological examination** | x | x | x | x | x | x | ||||
IFN-β BAbs*** | x | x | x | x | ||||||
Lab values# | x | x | x | x | ||||||
IFN-β bioavailability## | x | x | x | x | x | x | ||||
TPE | x | x | x | x | x | x | x | |||
(S)AEs assessment and reporting | x | Whenever (serious) adverse events occurs |
ABP, HR, Resp, body temperature, ECG;
Neurological examination, EDSS;
BAbs measured with ELISA before MxA expression;
Hb, WBC, PLT, electrolytes, TP, coagulation (APTT, PA, fibrinogen);
MxA mRNA expression (before IFN-β injection and 12 hours after injection). INF-β – interferon beta; BAbs – binding antibodies; MxA – myxovirus resistance protein A; mRNA – messenger RNA; TPE – therapeutic plasma exchange.